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Medical Device Design Specialist
3 weeks ago
Are you a creative and driven Medical Device Designer passionate about enhancing patients' lives through innovative medical technologies? Your vision has the power to transform lives.
As a seasoned Mechanical Architect in the medical device domain, you will lead the development of cutting-edge technologies that tackle complex healthcare challenges. Your design engineering expertise will be pivotal in crafting and optimizing devices that uphold the highest standards of performance, safety, and regulatory compliance.
You will collaborate with cross-functional teams including R&D, Quality Assurance, and Regulatory Affairs to turn visionary concepts into market-ready medical solutions.
**Key Responsibilities:**
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Conceptualize, design, develop, and optimize mechanical systems and sub-systems for medical devices from concept to production.
Design new products or components to meet specific performance, aesthetic, and functional requirements.
Create 3D models and detailed drawings using CAD software like Solidworks / Creo.
Conduct engineering analyses, including stress, thermal, and fluid dynamics simulations, to optimize mechanical designs and ensure proper function.
Select appropriate materials based on factors like mechanical properties, thermal stability, biocompatibility, durability, sterilization compatibility, and cost-effectiveness.
Develop and optimize products in sheet-metal, machining and plastic processing techniques (e.g. injection molding, extrusion, blow molding, thermoforming, and other plastic processing techniques).
Stay up to date with the latest advancements in materials science, plastic technologies, and manufacturing processes.
Conduct rigorous testing and validation of designed systems to ensure functionality, performance, and compliance with relevant medical device standards (e.g., FDA, EUMDR, CDSCO, ISO 13485).
Create and maintain accurate and comprehensive documentation of designs, specifications that includes interface design and specifications, test procedures, and verification reports for medical devices. Prepare progress reports, technical presentations, and updates for project stakeholders, regulatory submissions, and audits.
Ensure that all design and development activities adhere to relevant medical device regulations and standards.
Contribute to the development of new and innovative medical device technologies.
Participate in continuous learning and development within the field of medical devices.
